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临床试验/NCT01443572
NCT01443572已完成不适用

The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation

Yonsei University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in hepatic function

研究概览

简要总结

Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of inhalation anesthetic that minimally affects hepatic function is important. Therefore, the purpose of this study is to compare the postoperative recovery and hepatic function between desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients undergoing Kasai operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • patients with biliary atresia undergoing Kasai operation

排除标准

  • patients with congenital anomalies at major organs

研究组 & 干预措施

desflurane group

Experimental

干预措施: desflurane anesthetics (Drug)

sevoflurane group

Active Comparator

干预措施: sevoflurane anesthetics (Drug)

结局指标

主要结局

Change in hepatic function

时间窗: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days

Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte

Change in postoperative recovery

时间窗: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.

Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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